ES2341641T3 - Un dispositivo de bolsa de malla porosa expansible y su uso para cirugia osea. - Google Patents
Un dispositivo de bolsa de malla porosa expansible y su uso para cirugia osea. Download PDFInfo
- Publication number
- ES2341641T3 ES2341641T3 ES01955877T ES01955877T ES2341641T3 ES 2341641 T3 ES2341641 T3 ES 2341641T3 ES 01955877 T ES01955877 T ES 01955877T ES 01955877 T ES01955877 T ES 01955877T ES 2341641 T3 ES2341641 T3 ES 2341641T3
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- Prior art keywords
- bag
- cavity
- bone
- vertebra
- filling
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- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Abstract
Un sistema corrector de fractura por compresión vertebral que comprende: medios (14) para la creación de una cavidad (16) dentro de un hueso (10), una bolsa porosa expansible y una herramienta de relleno (20) construida para suministrar material de relleno óseo (19) a presión en la bolsa porosa; caracterizado por: los medios (14) para la creación de la cavidad (16) son un escariador dispuesto para formar una cavidad dentro de la vértebra (10); medios para la inserción de la bolsa porosa expansible (22) en la cavidad (16) dentro de la vértebra (10); y la herramienta (20) de relleno está dispuesta para inyectar el material de relleno óseo (19) a presión en la bolsa porosa (22), cuando está en su sitio en la cavidad (16) dentro de la vértebra, para expandir la bolsa porosa expansible (22) hacia los límites de la cavidad (16).
Description
Un dispositivo de bolsa de malla porosa
expansible y su uso para cirugía ósea.
Esta invención se refiere a un sistema corrector
de fractura por compresión vertebral.
Las patentes de los EE.UU. 5.549.679 y 5.571.189
para Kuslich describen un dispositivo y un método para la
estabilización del segmento espinal con un implante expansible de
tela porosa para su inserción en el interior de un disco escariado
que se carga con material para facilitar la fusión ósea. En la
presente invención, se usa una bolsa similar para tratar fracturas
por compresión de la columna vertebral.
Las patentes de los EE.UU. 5.108.404 y 4.969.888
para Scholten y otros describen un sistema para la fijación de
hueso osteoporótico mediante un globo inflable que compacta el hueso
para formar una cavidad en la que se inyecta cemento óseo después
de retirar el globo. La invención requiere el uso de fluoroscopia
para observar la inyección y para ayudar a prevenir las fugas de
cemento a través de fisuras en los huesos. Lamentablemente, tales
fugas se sabe que ocurren a pesar de estas precauciones. Dado que
una fuga puede provocar lesiones graves, incluyendo parálisis, es
necesario un dispositivo y un método mejorados.
La patente de EE.UU. 5.972.015 para Scribner y
otros describe un sistema de despliegue de un tubo catéter en el
interior de la vértebra y la expansión de un globo no poroso
configurado de manera especial ahí dentro para compactar el hueso
poroso para formar una cavidad. La solución del documento 5.972.015
de Scribner utiliza un globo no poroso que se infla dentro del
hueso para producir compresión. La cavidad así formada se puede
llenar después con cemento óseo.
Desafortunadamente, la bolsa utilizada por
Scribner puede romperse durante la expansión para compactar el
hueso esponjoso debido a salientes cortantes que se encuentran
dentro de la cavidad que se va a expandir, dando lugar a fugas del
medio de inflado. Además, el llenado de la cavidad formada
finalmente podría permitir la fuga de cemento óseo fuera de los
huesos, contra los vasos o los nervios lo que puede provocar
complicaciones no deseadas.
La presente invención consiste en una mejora de
todos los sistemas anteriores y evita las complicaciones que pueden
ocurrir con el sistema del documento de los EE.UU. 5.972.015.
De acuerdo con la invención, se proporciona un
sistema corrector de fractura por compresión vertebral que
comprende: medios para la creación de una cavidad dentro de un
hueso; una bolsa porosa expansible; y una herramienta de relleno
construida para suministrar material de relleno óseo a presión en la
bolsa porosa, caracterizado porque: los medios para la creación de
la cavidad son un escariador dispuesto para formar una cavidad
dentro de una vértebra; medios para la inserción de la bolsa porosa
expansible en la cavidad dentro de la vértebra; y la herramienta de
relleno se dispone para inyectar el material de relleno óseo a
presión en la bolsa porosa, cuando está en su lugar en la cavidad
dentro de la vértebra, para expandir la bolsa porosa expansible
hacia los límites de la cavidad.
Así, la invención permite un método para
corregir las fracturas por compresión de la columna mediante el
acceso en primer lugar y perforación en el tejido o hueso dañado y
escariado de la zona dañada y/o enferma usando cualquiera de los
procedimientos actualmente aceptados o se puede preparar la zona
dañada al expandir una bolsa dentro del tejido dañado el hueso debe
ser estabilizado.
El escariador puede ser cualquier escariador
convencional. Ejemplos de escariadores se describen en la patente
de EE.UU. nº. 5.015.255. Se conocen y se pueden utilizar otros
ejemplos de escariadores. Después de que el hueso dañado o tejido
ha sido eliminado por el escariador, se pueden insertar unos medios
de reparación ósea en la cavidad así formada, a través de un
catéter y una bolsa de tela expansible como se describe en las
patentes de EE.UU. 5.549.679 y 5.571.189.
Una descripción detallada de la invención se
describe a continuación en esta memoria con referencia específica
hecha a los dibujos en los que:
La Fig. 1 es una vista en alzado lateral de la
vértebra que está fracturada y necesita reparación;
La Fig. 2 es una vista lateral de la vértebra de
la Fig. 1 que está siendo escariada con una herramienta de
escariado desde la vía de acceso anterior;
La Fig. 3 es una vista superior de la vértebra
de la Fig. 1 que muestra el escariador formando un par de cavidades
dentro de la vértebra desde la vía de acceso anterior;
La Fig. 4 es una vista en alzado lateral de la
vértebra de la Fig. 2 que muestra la colocación de una bolsa de
tela expansible de la invención;
La Fig. 5 es una vista en alzado superior de la
vértebra de la Fig. 3 que muestra la segunda de dos bolsas de tela
expansibles de la invención que está siendo colocada;
La Fig. 6 es una vista lateral de la vértebra
que está siendo escariada desde una vía de entrada posterior;
La Fig. 7 es una vista superior de la vértebra
de la Fig. 6 con una bolsa en su lugar y una segunda cavidad que se
está escariando;
La Fig. 8 es una vista en alzado lateral de la
vértebra de la Fig. 6 con una bolsa de tela expansible de la
invención en su sitio; y
La Fig. 9 es una vista superior de la vértebra
de la Fig. 7 con una bolsa inflada y la segunda bolsa
desinflada.
En la siguiente descripción detallada se
utilizan números de referencia similares para describir elementos
similares de las diferentes figuras.
La Fig. 1 muestra una vértebra típica 30 que
tiene fracturas 12 por compresión, que está necesitada de
reparación. Como se indicó anteriormente la parte dañada de la
vértebra 10 es escariada. Por ejemplo, la Fig. 2 muestra un
escariador 14 entrando en la vértebra 10 desde la parte anterior
para hacer una abertura 15 y la cavidad 16. Alternativamente, se
pueden formar varias cavidades 16 tal como se muestra en la Fig.
3.
En la Fig. 4 se ve un tubo de suministro o
catéter 20 en el proceso de suministro de una bolsa de tela
expansible 22 dentro de la vértebra 10 o en una cavidad 16 presente
allí dentro. Una vez que la bolsa 22 se coloca dentro de la
vértebra 10, la bolsa 22 puede ser inflada o expandida hacia los
límites de la cavidad 16 formada así por medio de la inserción o la
inyección de material de relleno 19 en el interior 21 de la bolsa
22.
La Fig. 5 muestra una única bolsa rellena 22 de
tela expansible en su sitio con una segunda bolsa expansible que se
está insertando y expandiendo dentro de la cavidad 16.
Las Figs. 6-9 ilustran un
procedimiento en el que la abertura 15 y la cavidad 16 se crean por
la parte posterior. Independientemente de la dirección a través de
la que se opera la vértebra 10, en todas formas, la cavidad 16 que
se forma se rellena después con material óseo de sustitución
aceptable.
El material óseo de sustitución 19 puede ser uno
o más de los siguientes, o cualquier material biocompatible que se
considere que tiene la respuesta fisiológica deseada:
- A)
- Material óseo desmineralizado, injerto de hueso morselizado, cortical, esponjoso, o córtico-esponjoso, incluyendo autoinjerto, aloinjerto o el xenoinjerto.
- B)
- Cualquier sustituto de injerto óseo o combinación de sustitutos de injerto óseo, o combinaciones de injertos óseos y sustitutos de injerto óseos, o sustancias de inducción de hueso, incluyendo pero no limitado a: fosfatos tricalcio, sulfatos tricalcio, carbonatos tricalcio, hidroxiapatita, proteína ósea morfogénica, derivados óseos calcificados y/o descalcificados.
- C)
- cementos óseos, tales como cementos óseos cerámicos y de polimetilmetacrilato.
\vskip1.000000\baselineskip
El material de sustitución de hueso se inserta
en la bolsa 22 a través de una aguja, un catéter 20 u otro tipo de
herramienta de relleno. El material de sustitución de hueso expande
la bolsa hacia los límites de la cavidad 16.
La bolsa 22 puede ser una bolsa de tela pequeña,
aproximadamente de uno a cuatro centímetros de diámetro, siendo más
o menos de forma esférica, aunque se pueden utilizar otras formas
elípticas y otras formas geométricas. La bolsa es flexible y
maleable antes de que su espacio interior 21 se rellene con el
contenido que se describirá. El material de la bolsa 22 puede ser
configurado para asumir la forma de la cavidad en la que se coloca
la bolsa. Si bien en este estado inicial, la bolsa puede pasar, sin
inflar, a través de un portal o tubo relativamente pequeño, quizás
de aproximadamente tres milímetros a aproximadamente un cm de
diámetro.
La bolsa 22, tal como se puede observar mejor en
la figura 9, se construye de una manera especial y novedosa. La
bolsa 22 puede ser construida de una tela 23. La tela 23 puede ser
tejida, tramada, trenzada o moldeada con forma con una densidad que
permita la entrada y la salida de fluidos y soluciones y permitirá
el crecimiento interno y el crecimiento a través de vasos
sanguíneos y tejido fibroso y trabecula ósea, pero la porosidad de
la tela es lo suficientemente estrecha para retener las partículas
pequeñas de material encerrado, tal como injerto óseo o sustituto
de injerto óseo triturado, tales como hidroxiapatita u otros
materiales biocompatibles osteoinductivos conocidos por promover la
formación de hueso. La tela 23 define una pluralidad de poros 25.
En general, los poros 25 de la tela 23 tendrá un diámetro de
aproximadamente 0,25 mm o menos, a aproximadamente 5,0 mm. El
tamaño se selecciona para permitir el crecimiento tisular a la vez
que contiene el material compactado en la bolsa. Si se utiliza
cemento óseo u otro material que no experimentará crecimiento óseo,
los poros 25 pueden ser mucho más estrechos para evitar la salida
de los medios desde dentro de la bolsa 22 afuera a la cavidad 16.
Esto evita las fugas que podrían afectar a los nervios, vasos
sanguíneos o similares si se les permite salir del hueso.
\newpage
Uno o más de los poros 25 puede ser usado como
abertura 27 de relleno, en la que la tela 23 puede ser manipulada
para ampliar un poro hasta un diámetro potencialmente superior a 5
mm pero no más de aproximadamente 1 cm. Preferentemente, la
abertura 27 de llenado es de diámetro inferior a aproximadamente 5
mm. Este poro/abertura de llenado 27 es suficientemente amplio para
permitir que un catéter, aguja, tubo de llenado u otro dispositivo
inserten o inyecten material de relleno que pasa a través de la tela
23 y en el interior 21 de la bolsa 22, sin dañar la integridad de
la bolsa 22.
Cuando la bolsa 22 está totalmente llena de
material de relleno, la bolsa formará una forma de
auto-retención que sustancialmente llena la cavidad
16. Una vez lo suficientemente repleta, la herramienta de relleno
utilizada para colocar material de relleno en el interior 21 de la
bolsa se retira de la abertura 27. Cuando la abertura 27 no es un
poro 25, sino una abertura distinta y separada en la bolsa 22, la
abertura 27 puede tener un diámetro fijado que requiere obturación
tal como por ligado, fijación, soldadura, encolado o cualquier otro
medio de cierre de la apertura 27 después de que la bolsa se haya
llenado. Cuando la abertura 27 es un poro 25, tras la retirada del
catéter o herramienta de relleno de la abertura 27 la tela 23 se
contraerá para reducir el diámetro de la abertura 27 para ser
substancialmente similar al de los otros poros.
El tamaño y la densidad de los poros determinan
la facilidad o dificultad con que los materiales pueden pasar a
través de la malla. Por ejemplo, unos poros muy pequeños (<0,5
mm) prohíben el paso de todas las partículas excepto las más
pequeñas y los líquidos. El tamaño de poro y la densidad pueden ser
controlados en el proceso de fabricación, de manera que el producto
final estaría adaptado a las necesidades del cirujano. Por ejemplo,
si se utilizara cemento óseo de metilmetacrilato, el tamaño de los
poros tendría que ser muy pequeño, tal como aproximadamente menos
de 0,5 mm a aproximadamente 1,0 mm, mientras que, cuando se utilizan
injertos óseos o gránulos de cerámica biocompatibles, se puede
permitir tamaño de poros que puede ir desde aproximadamente 1,0 mm
a aproximadamente 5,0 mm o más. El hecho de que la tela 16 es
adecuadamente porosa le permite restringir el flujo potencialmente
peligroso del material de relleno fuera de los confines de la
bolsa.
La tela es ligera, biocompatible, flexible y
fácil de manejar, y tiene muy buena resistencia a la tracción, y
así es improbable que se desgarre o desmenuce durante la inserción y
el inflado. Cuando se infla el dispositivo, el dispositivo se
expande hasta rellenar una cavidad 16 previamente excavada.
El uso del término "tela" en esta memoria
se pretende que incluya la definición habitual de ese término y que
incluya cualquier material que funcione como una tela, es decir, la
"tela" de la invención debe tener una pluralidad de poros 25,
a través de los que se permite el flujo de material y de líquido
bajo las condiciones descritas, y la "tela" debe ser lo
suficientemente flexible para permitir que sea aplastada e insertada
en una abertura más pequeña que el tamaño de la bolsa inflada.
La bolsa 22 no tiene por qué ser tejida y puede
ser moldeada o formada de otra manera como se conoce bien en la
técnica. El material preferido puede proporcionar la capacidad de
adaptar tasas de absorbencia biológica. Se puede utilizar cualquier
material de tipo sutura utilizado médicamente para formar la bolsa
22. La bolsa puede estar formada por plástico o incluso de metal.
En al menos una realización la bolsa 22 se forma utilizando una
combinación de hilo reabsorbible y/o no reabsorbible. La bolsa 22
puede incluir una abertura de llenado 27 que puede ser un casquillo
que puede ser un plástico, cerámica o metal bioabsorbible y/o no
bioabsorbible. La apertura 27 también puede ser tal como
hidroxiapatita o podría ser de plástico o de metal. La abertura 27
también puede ser caracterizada como un poro 25, en la que un poro
25 de la tela 23 se ha expandido para permitir que un catéter 20 u
otro dispositivo de llenado pase al interior 21 de la bolsa 22. La
bolsa 22, puede formarse a partir de un material sólido al que se
añaden perforaciones. La bolsa 22 puede ser parcial o totalmente
absorbible, metal, plástico, tejido, sólido, una película o un globo
extruido.
El sistema de la presente invención puede ser
utilizado para tratar una vértebra dañada 10, de acuerdo con los
siguientes procedimientos descritos en las figuras
1-9:
Inicialmente, la vértebra 10 que necesita
reparación se expone quirúrgicamente mediante la formación de al
menos una cavidad 16. La cavidad o cavidades 16 se forman por
escariado. El escariado puede conseguirse por diversos medios tales
como el uso de un escariador 14, como se muestra por ejemplo en la
patente de EE.UU. nº. 5.015.255. A continuación, la bolsa de malla
sin expandir o Dispositivo de Bolsa de Tela Expansible (EFBD:
Expandable Fabric Bag Device) 22 se inserta en la cavidad o
cavidades a través de un catéter 20 o por otros medios. En algún
momento, el material de relleno 19 está preparado para la inserción
o la inyección en el EFBD 22. A continuación de la preparación del
material de relleno 19, el material se inyecta o se inserta de otra
manera en la bolsa 22 usando suficiente presión para llenar la bolsa
22 hasta su estado expandido, produciendo así rigidez y tensión
dentro de la cavidad o cavidades 16 para alcanzar el grado de
corrección requerido en virtud de las fracturas por compresión. Por
último, la abertura de llenado 27 se cierra para impedir la salida
de material de inflado 19.
Claims (1)
1. Un sistema corrector de fractura por
compresión vertebral que comprende: medios (14) para la creación de
una cavidad (16) dentro de un hueso (10), una bolsa porosa
expansible y una herramienta de relleno (20) construida para
suministrar material de relleno óseo (19) a presión en la bolsa
porosa; caracterizado por: los medios (14) para la creación
de la cavidad (16) son un escariador dispuesto para formar una
cavidad dentro de la vértebra (10); medios para la inserción de la
bolsa porosa expansible (22) en la cavidad (16) dentro de la
vértebra (10); y la herramienta (20) de relleno está dispuesta para
inyectar el material de relleno óseo (19) a presión en la bolsa
porosa (22), cuando está en su sitio en la cavidad (16) dentro de la
vértebra, para expandir la bolsa porosa expansible (22) hacia los
límites de la cavidad (16).
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US21985300P | 2000-07-21 | 2000-07-21 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2341641T3 true ES2341641T3 (es) | 2010-06-24 |
Family
ID=37434183
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES01955877T Expired - Lifetime ES2341641T3 (es) | 2000-07-21 | 2001-07-20 | Un dispositivo de bolsa de malla porosa expansible y su uso para cirugia osea. |
Country Status (3)
| Country | Link |
|---|---|
| US (4) | US20020068974A1 (es) |
| DE (1) | DE60141653D1 (es) |
| ES (1) | ES2341641T3 (es) |
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-
2001
- 2001-07-20 ES ES01955877T patent/ES2341641T3/es not_active Expired - Lifetime
- 2001-07-20 DE DE60141653T patent/DE60141653D1/de not_active Expired - Lifetime
- 2001-07-20 US US09/909,667 patent/US20020068974A1/en not_active Abandoned
-
2003
- 2003-05-16 US US10/440,036 patent/US7226481B2/en not_active Expired - Lifetime
-
2005
- 2005-11-18 US US11/282,910 patent/US20060149379A1/en not_active Abandoned
-
2013
- 2013-09-03 US US14/016,866 patent/US9526621B2/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| DE60141653D1 (de) | 2010-05-06 |
| US20060149379A1 (en) | 2006-07-06 |
| US7226481B2 (en) | 2007-06-05 |
| US20020068974A1 (en) | 2002-06-06 |
| US20140067066A1 (en) | 2014-03-06 |
| US20040073308A1 (en) | 2004-04-15 |
| US9526621B2 (en) | 2016-12-27 |
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